A Randomized Clinical Trial On Early Pregnancy Failure

关于早期妊娠失败的随机临床试验

• 批准号: 7208944
• 负责人: JIM ZHANG
• 金额: --
• 依托单位: EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7208944
• 关键词: abortifacients; clinical trials; drug screening /evaluation; embryo /fetus death; female; female reproductive system surgery; hemorrhage; human subject; human therapy evaluation; interview; oxytocics; patient oriented research; prostaglandin E; prostaglandin analogs; satisfaction; spontaneous abortion; women' s health

Background: Medical management with misoprostol for early pregnancy failure has been increasingly used. However, the efficacy, safety and acceptability of this treatment have yet to be established in a large randomized trial. Methods: This multicenter trial randomized 652 women with a first trimester pregnancy failure (anembryonic gestation, fetal demise, incomplete and inevitable spontaneous abortion) to receive either vacuum aspiration (VA, standard of care) or 800 ig vaginal misoprostol in a 1:3 ratio. Subjects receiving misoprostol returned on Day 3. If the expulsion of POC was incomplete, a second dose of 800 ig vaginal misoprostol was given. On Day 8, if the expulsion was still incomplete, VA was offered. On Day 15, all subjects returned for follow-up visit. A telephone interview was conducted on Day 30. Failure was defined as VA (for the misoprostol treatment group) or reaspiration (for the VA group) for any reason within 30 days after the initial treatment. The study was powered to test whether the success rate in the misoprostol group was lower than that in the VA group by 18%. If the difference in success rate between the two groups did not exceed 18%, the treatments would be considered equivalent. Results: Overall, 491 and 161 women, respectively, were randomized to medical or surgical management. Baseline characteristics of the two groups were comparable. In the misoprostol group, 71% of women had complete expulsion by day 3 and 85% by day 8. Overall, treatment failures occurred in 3% of the VA group and 15% of the misoprostol group (difference = 12%, 90% CI 9, 16%). Hemorrhage or endometritis that required hospitalization was rare (< 1%) and there were no differences between the two groups. Emergency hospital visit after the treatment occurred to 3.1% and 2.0% of women who received medical and surgical treatment, respectively (p = 0.59). 78% of women would choose misoprostol again and 83% recommend to others if needed. The acceptability was not different from that in the VA group. Conclusion: Treatment of early pregnancy failure with 800 mg misoprostol per vagina is efficacious and safe with a success rate of around 85%. The risks for hemorrhage and endometritis are very low, and the side-effects are tolerable. It is an acceptable treatment to the majority of the participants.

背景：使用米索前列醇治疗早期妊娠失败的药物治疗已被越来越多地使用。然而，这种治疗的有效性、安全性和可接受性尚未通过大型随机试验确定。 方法：这项多中心试验将 652 名妊娠早期妊娠失败（无胚胎妊娠、胎儿死亡、不完全性和不可避免的自然流产）的妇女随机分为接受真空抽吸（VA，标准护理）或 800 ig 阴道米索前列醇（按 1:3 的比例）。接受米索前列醇的受试者在第 3 天返回。如果 POC 排出不完全，则给予第二剂 800 ig 阴道米索前列醇。第 8 天，如果驱逐仍未完成，则提供 VA。第15天，所有受试者返回进行随访。第 30 天进行电话访谈。失败定义为初次治疗后 30 天内因任何原因出现 VA（对于米索前列醇治疗组）或呼吸（对于 VA 组）。该研究旨在检验米索前列醇组的成功率是否比 VA 组低 18%。如果两组的成功率差异不超过18%，则视为治疗等效。 结果：总体而言，分别有 491 名和 161 名女性被随机分配接受药物或手术治疗。两组的基线特征具有可比性。在米索前列醇组中，71% 的女性在第 3 天完全排出，85% 的女性在第 8 天完全排出。总体而言，VA 组有 3% 的患者治疗失败，米索前列醇组有 15% 的患者出现治疗失败（差异 = 12%、90% CI 9、16%）。需要住院治疗的出血或子宫内膜炎很少见（< 1%），并且两组之间没有差异。接受药物治疗和手术治疗的女性中，分别有 3.1% 和 2.0% 的患者在治疗后前往医院急诊（p = 0.59）。 78% 的女性会再次选择米索前列醇，83% 的女性会在需要时推荐给其他人。接受度与 VA 组没有什么不同。 结论：每次阴道800mg米索前列醇治疗早期妊娠失败有效且安全，成功率约为85%。出血和子宫内膜炎的风险非常低，而且副作用是可以忍受的。 It is an acceptable treatment to the majority of the participants.